BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRO CHOLANGIOGRAPHY SE T

    MDR report key: 2421303 · Received January 16, 2012

    Report

    Report Number
    2242445-2012-00005
    Event Type
    Injury
    Date Received
    January 16, 2012
    Date of Event
    January 5, 2012
    Report Date
    January 12, 2012
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    GBZ
    PMA / PMN Number
    K905229
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ATTEMPTING TO THREAD THE CATHETER INTO THE CYSTIC DUCT IT WAS OBSERVED THAT A SMALL PORTION OF THE TIP OF THE CATHETER HAD BROKEN OFF. THE CATHETER WAS REMOVED FROM THE PT AND THE OPERATING ROOM FIELD AS WAS THE PIECE THAT HAD BROKEN OFF. IT WAS FOUND TO BE IN ITS ENTIRETY AND REMOVED FROM THE SURGICAL FIELD. ON (B)(6) 2012 - F/U INFO CONFIRMS THAT THE CATHETER DID SEPARATE AND THE SMALL PIECE WAS SURGICALLY REMOVED DURING THE PROCEDURE FROM THE FEMALE PT. ANOTHER KIT WAS OPENED AND USED SUCCESSFULLY FOR THE PT. THERE WAS A DELAY IN TREATMENT WITH NO HARM TO THE PT. THERE WAS A DELAY IN TREATMENT WITH NO HARM TO THE PT, NO PT DEATH, AND NO PT COMPLICATIONS WERE REPORTED. THE PT OUTCOME WAS A SUCCESSFUL REMOVAL OF THE PT'S GALL BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRO CHOLANGIOGRAPHY SE T CHOLANGIOGRAPHY CATHETER PRODUCTS GBZ ARROW INTERNATIONAL INC MF1104699

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention